18 - 19 September 2019, Abu Dhabi, UAE

Day 2


Thursday: September 19, 2019

08:00  Registration and Refreshments
   
08:55 Opening Remarks by the Chairman

Prof. Gernod Dittel
CEO, Dittel Engineering
   
SESSION 3: SECTOR FOCUS-CLEAN LIFE SCIENCES
   
09:00 Cleanrooms Design and Construction: Stages and Typical Mistakes
 

• Key stages in design and construction
• Delivery of project from start to turnkey
• Cleanroom management in pharmaceuticals and healthcare

Hitesh Upreti
MD, Zenufa

   
09:30 Cleanroom Garments from a Quality Risk Management Perspective

• Understanding “people in cleanroom”
• Reviewing and resolving the major contamination factors
• Staff gowning and personnel behavior

Matts Ramstorp
BioTekPro, Sweden

   
10:00 ePTFE and eFRM membrane HEPA/ULPA filters for pharmaceutical and microelectronics application
  • ePTFE and eFRM membrane HEPA/ULPA filters, structure and media properties vs glass media
• validation of ePTFE and eFRM membrane HEPA/ULPA filters
• risk reduction, energy savings
• benefits of ePTFE and eFRM membrane HEPA/ULPA filters

Dr. Marc Schmidt
Director Research and Development – Europe, AAF International
   
10:30 Coffee and Networking 
   
11:00 GMP Annex 1: A new Dawn in Garment Selection
  • Understanding the impact of GMP Annex 1 on contamination control strategies
• Different garment systems and results of the DuPont study on reusable garments
• Value chain assessment

Jean-Francois Teneul
Global Life Sciences Market Leader – Personal Protection, DuPont de Nemours 
   
11:30 Sterile Compounding Program Elements: Quality Control and Best Practice 
 

Provides the necessary information and guidance, to assure the production of high-quality, compounded sterile preparations:
• Employee Education
• Compounding Process
• Quality Assurance

Dr. Nura Al Banyan
Lead Pharmacist, King Fahd Medical Centre 

   
12:00 Lab Cleanliness Assessment for Infection Prevention and Control
  • Check on microbial contaminants
• Limitations of sampling equipment
• Sterility assurance in environment monitoring

Dr. Najiba Abdul Razzaq
Head of Infection Control, Ministry of Health, UAE
   
12:20 Interactive Panel Discussion
   
13:00 Prayer and Lunch Break
 
14:00  Containment Room Applications
 

• Sealing requirements in clean and contained Rooms
• Classic methods of sealing cable and pipe entries and the cost of failure
• Optimized cable and pipe sealing methods
• Case study
• Need for specifications on effective sealing methods

Mohammed Toubasi
Technical Manager, Roxtec

 

 

14:30  Is the IVF Industry Ready for Cleanroom Technology?
 

The talk will outline the special considerations that are paramount within a laboratory for successful embryo culture and high pregnancy rates with emphasis on laboratory environment and air quality. The current international standards and guidelines will be discussed and the need for the implementation of cleanroom technologies in the sector. 

• The IVF laboratory and its processes
• Air quality and the challenges of In Vitro Embryo culture
• Current standards and guidelines
• Future trends and developments

Giles Palmer
Business and Quality Manager, London Women's Clinic

 

 

 15:00 Microbiology in Cleanrooms and Isolators used for Sterility Testing
  • Regulatory Requirements
• State of the art Sterility Testing
• Qualification of Isolators
• Microbiological Monitoring
• Comparison Isolator vs. Cleanroom

Dr. Timo Krebsbach
Managing Director, HHAC Laboratory Heusler GmbH
   
   
 16:00 Closing Remarks and End of Cleanzone Middle East 2019

 

DAY 1